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The Federal Trade Commission is currently accepting public comments on an application by Teva Pharmaceutical Industries Ltd. requesting that the Commission reopen and modify its decision and order in connection with the 2012 merger of Watson Pharmaceuticals, Inc. and Actavis Inc.

The Commission alleged that the merger risked lessening future competition in the U.S. markets for a number of generic drugs, including the generic version of the abuse-resistant opioid painkiller sold under the brand name Embeda. The 2012 decision and order required Watson and Actavis to supply Embeda to Pfizer Inc. for a period not to exceed four years after Pfizer’s relaunch of Embeda, which occurred in January 2015. At the time of the 2012 decision and order, Pfizer did not have the capability to independently manufacture Embeda. The decision and order also required Watson and Actavis to assist in the transfer of technology for manufacturing Embeda to Pfizer or a third party. In 2016, Teva acquired the generic pharmaceutical business of Allergan plc, assumed Actavis’s rights and obligations under the Embeda supply agreement, and continued Watson’s plans to develop a generic version of Embeda.

Teva seeks to extend, at Pfizer’s request, the Embeda supply agreement for an additional period. Teva claims that Pfizer has not yet completed the technology transfer for Embeda manufacturing to a third party and that without Teva’s supply of Embeda, Pfizer will be unable to supply patients with Embeda after December 2018. According to Teva’s application, “the public interest heavily favors removing or extending” the supply agreement past December 2018, because doing so will “preserve Pfizer’s ability to supply patients with Embeda.” Teva also claims that extending the Embeda supply agreement “will not impact Teva’s plans to introduce a generic version of Embeda.”

The Commission will decide whether to approve the application after a 30-day public comment period, which expires on Nov. 23, 2018. Comments can be filed electronically or sent to: FTC Office of the Secretary, 600 Pennsylvania Ave., N.W., Washington. (FTC File No. 1210132; the staff contact is the staff contact is Elizabeth Piotrowski, Bureau of Competition, 202-326-2623.)

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Contact Information

Betsy Lordan
Office of Public Affairs